The following data is part of a premarket notification filed by Cp Medical with the FDA for Cp Sleeve And River Sleeve.
| Device ID | K034062 |
| 510k Number | K034062 |
| Device Name: | CP SLEEVE AND RIVER SLEEVE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
| Contact | Mary Ann Greenawalt |
| Correspondent | Mary Ann Greenawalt CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-31 |
| Decision Date | 2004-01-30 |
| Summary: | summary |